Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 15, 2020
Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.
Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the…
Medacta Usa Inc recalled Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055,… - a moderate-severity action.
Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055,… was recalled by Medacta Usa Inc in January 15, 2020. Reason: Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that…. Check the official notice for the remedy. Verify recall #Z-0775-2020 with the FDA Devices before acting.
The recall
Medacta Usa Inc issued this moderate-severity FDA Devices recall-Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that….
- Moderate
- severity level
- 207 units
- affected scope
- Class II
- classification
- January 15, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0775-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0775-2020) was formally reported on January 15, 2020, with the manufacturer initiating the action on November 4, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Medacta Usa Inc is listed as the recalling firm, operating out of Memphis, TN. Federal records list the affected scope as 207 units.
The documented reason for this recall is: Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral diaphysis. Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of KY, NJ, IL, SC, CA, TX, ID, AR, OH.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
207 units
Related Recalls
6
3 from same agency
Product description
Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.
Reason for recall
Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral diaphysis.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0775-2020 |
| Date reported | January 15, 2020 |
| Date initiated | November 4, 2019 |
| Recalling firm | Medacta Usa Inc |
| Firm location | Memphis, TN |
| Affected scope | 207 units |
| Distribution | US Nationwide distribution in the states of KY, NJ, IL, SC, CA, TX, ID, AR, OH. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0775-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.. Recalled by Medacta Usa Inc. Units affected: 207 units.
Why was this product recalled? ▼
Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral diaphysis.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 15, 2020. Severity: Moderate. Recall number: Z-0775-2020.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of KY, NJ, IL, SC, CA, TX, ID, AR, OH..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0775-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 15, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.